Regulatory agencies, such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require comprehensive stability data as part of the submission process for new drug applications. These entities have established specific guidelines that pharmaceutical companies must follow to ensure that their products meet safety and efficacy standards.
Formulation refers to the process of combining APIs with other substances to develop a viable drug product. These additional substances, often referred to as excipients, can include fillers, binders, preservatives, and stabilizers. The formulation is crucial because it determines the drug's stability, absorption, distribution, metabolism, and excretion (ADME) properties.
api and formulation in pharma